Therapeutic Goods Administration


Laboratories Branch Biotherapeutics

Accreditation No.


Site No.


Date of Accreditation

30 Jun 1989


1 Tindal Lane
Canberra Airport, ACT 2609


Ms Erin Fitzgerald P: +61 (02) 62894107


Services conditionally available to external clients

Scope of Accreditation

Laboratories Branch Biotherapeutics

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Biological analysis of human and veterinary medicines including vaccines Biological medicines; Vaccines Content; Identity; Potency; Purity Cell culture; Chromatography; Coagulation; Electrophoresis; Enzyme activity; Enzyme linked immunosorbent assay (ELISA); Immunodiffusion; Mass spectrometry (MS); Polymerase chain reaction (PCR)

By BP, PhEur, USP, manufacturer and in-house methods for Capillary electrophoresis, Cell culture, Electrophoresis, ELISA,  Enzyme activity, General laboratory procedures, HPLC, Influenza, PCR and Sysmex

Pharmaceuticals LAL bacterial endotoxin Limulus amoebocyte lysate (LAL)

By BP, PhEur, USP, manufacturer and in-house methods for Bacterial Endotoxin

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.